Spinal implant system and method

ABSTRACT

A method for treating a spine includes creating a single minimally invasive incision in tissue; manipulating a lateral portion without manipulating a contralateral portion of the tissue to deliver fasteners and a rod through the incision, the fasteners being delivered along cortical trajectories disposed in alignment with vertebral levels; fastening the fasteners with the vertebral levels adjacent the lateral portion; connecting the rod with the fasteners; manipulating the contralateral portion without manipulating the lateral portion to deliver fasteners and a rod through the incision, the fasteners being delivered along cortical trajectories disposed in alignment with the vertebral levels; fastening the fasteners with the vertebral levels adjacent the contralateral portion; and connecting the rod with the fasteners. Systems and implants are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to asurgical system for implant delivery to a surgical site and a method fortreating a spine.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, tumor, and fracture mayresult from factors including trauma, disease and degenerativeconditions caused by injury and aging. Spinal disorders typically resultin symptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes fusion, fixation, correction, discectomy, laminectomy andimplantable prosthetics. As part of these surgical treatments, spinalconstructs, such as, for example, bone fasteners, spinal rods andinterbody devices can be used to provide stability to a treated region.For example, during surgical treatment, surgical instruments can be usedto deliver components of the spinal constructs to the surgical site forfixation with bone to immobilize a joint. This disclosure describes animprovement over these prior art technologies.

SUMMARY

In one embodiment, a method for treating a spine is provided. The methodcomprises the steps of: creating a single minimally invasive incision intissue of a body along a substantially sagittal plane of the body;manipulating a lateral portion of the tissue without manipulating acontralateral portion of the tissue to deliver a first fastener, asecond fastener and a first spinal rod through the incision, the firstfastener being delivered along a cortical trajectory disposed inalignment with a first vertebral level and the second fastener beingdelivered along a cortical trajectory disposed in alignment with asecond vertebral level; fastening the first fastener with the firstvertebral level adjacent the lateral portion; fastening the secondfastener with the second vertebral level adjacent the lateral portion;connecting the first spinal rod with the fasteners; manipulating thecontralateral portion without manipulating the lateral portion todeliver a third fastener, a fourth fastener and a second spinal rodthrough the incision, the third fastener being delivered along acortical trajectory disposed in alignment with the first vertebral leveland the fourth fastener being delivered along a cortical trajectorydisposed in alignment with the second vertebral level; fastening thethird fastener with the first vertebral level adjacent the contralateralportion; fastening the fourth fastener with the second vertebral leveladjacent the contralateral portion; and connecting the second spinal rodwith the third and fourth fasteners. In some embodiments, implants andsystems are disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a plan view of one embodiment of a system in accordance withthe principles of the present disclosure disposed with a body;

FIG. 2 is a cross section view of components of the system and the bodyshown in FIG. 1;

FIG. 3 is a plan view of one embodiment of trajectory for vertebrae ofthe body shown in FIG. 1;

FIG. 4 is a top view of components of the system and the body shown inFIG. 1;

FIG. 5 is a plan view of components of the system and the body shown inFIG. 1;

FIG. 6 is a cross section view of components of the system and the bodyshown in FIG. 1; and

FIG. 7 is a plan view of components of the system and the body shown inFIG. 1.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a surgical system for implant delivery to a surgical site and amethod for treating a spine. In one embodiment, the systems and methodsof the present disclosure are employed with a spinal joint and fusion,for example, with a cervical, thoracic, and/or lumbar region of a spine.In one embodiment, the systems and methods can be employed with a spinalfusion, such as, for example, a posterior joint fusion.

In one embodiment, the system is employed with a method for implantingcomponents of a system with a body of a patient when the body isdisposed in a lateral position with a surgical fixed surface, such as,for example, a surgical table. In some embodiments, the systems andmethods of the present disclosure can be employed with the body disposedin a prone position. In some embodiments, the systems and methods of thepresent disclosure can be employed with a direct lateral interbodyfusion procedure. In one embodiment, the method includes implanting aplate through a lateral incision to support a selected side, such as,for example, a lateral side after inserting an interbody implant andimplanting unilateral bone screws to support a contra-lateral side.

In one embodiment, the method includes inserting bone fasteners, suchas, for example, bone screws into vertebrae of a patient along acortical trajectory for bilateral fixation without moving the patientfrom an initial position, such as, for example, a lateral position. Insome embodiments, the cortical trajectory is modified such that anextender disposed with vertebrae does not contact a spinous process ofthe vertebrae. In one embodiment, the cortical trajectory is 1-2millimeters (mm) lateral from a starting point to provide space for anextender. In some embodiments, the cortical trajectory allows bonescrews to be positioned on a lateral and a contralateral side of thevertebrae when a patient is in the lateral position.

In one embodiment, at least two spinal rods are placed through oneminimally invasive incision without creating a second incision on eachside of the vertebrae. In one embodiment, the method includes insertingan interbody vertebral spacer between vertebrae without rotating thepatient. In one embodiment, bone screws are placed in the lateral andcontralateral sides of the vertebrae. In one embodiment, the bone screwson the same vertebral level of vertebrae are substantially parallel.

In some embodiments, the method is used with surgical navigation, suchas, for example, fluoroscope or image guidance. In some embodiments, thepresently disclosed systems and methods reduce operating time for asurgical procedure and reduce radiation exposure due to fluoroscope orimage guidance, for example, by eliminating procedural steps and patientrepositioning by implanting system components in one body position.

In one embodiment, the systems and methods of the present disclosure caninclude making a percutaneous cortical incision, which can include onesmall centerline incision; pulling back tissue and inserting extenderson a side, such as, for example, a lateral side of a construct toimplant bone fasteners; passing a spinal rod through the extenders andfasteners and removing the extenders; and pulling back tissue andinserting extenders on a side, such as, for example, a contra-lateralside of a construct to implant bone fasteners; passing a contra-lateralspinal rod through the extenders and fasteners and removing theextenders.

In one embodiment, one or all of the components of the surgical systemare disposable, peel-pack, pre-packed sterile devices. One or all of thecomponents of the surgical system may be reusable. The surgical systemmay be configured as a kit with multiple sized and configuredcomponents.

In one embodiment, the present disclosure may be employed to treatspinal disorders such as, for example, degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor and fractures. In oneembodiment, the present disclosure may be employed with other osteal andbone related applications, including those associated with diagnosticsand therapeutics. In some embodiments, the disclosed surgical system andmethods may be alternatively employed in a surgical treatment with apatient in a prone position, supine position, lateral position and/oremploy various surgical approaches to the spine, including anterior,posterior, posterior mid-line, direct lateral, postero-lateral, and/orantero-lateral approaches, and in other body regions. The presentdisclosure may also be alternatively employed with procedures fortreating the lumbar, cervical, thoracic, sacral and pelvic regions of aspinal column. The system and methods of the present disclosure may alsobe used on animals, bone models and other non-living substrates, suchas, for example, in training, testing and demonstration.

The present disclosure may be understood more readily by reference tothe following detailed description of the embodiments taken inconnection with the accompanying drawing figures, which form a part ofthis disclosure. It is to be understood that this application is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting. Also, as used in thespecification and including the appended claims, the singular forms “a,”“an,” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

Further, as used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. Also, as used in the specificationand including the appended claims, the term “tissue” includes softtissue, ligaments, tendons, cartilage and/or bone unless specificallyreferred to otherwise.

The following discussion includes a description of a surgical system andrelated methods of employing the surgical system in accordance with theprinciples of the present disclosure. Alternate embodiments are alsodisclosed. Reference is made in detail to exemplary embodiments of thepresent disclosure, which are illustrated in the accompanying figures.Turning to FIGS. 1-7, there are illustrated components of a surgicalsystem, such as, for example, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites, depending on the particular application and/orpreference of a medical practitioner. For example, the components ofspinal implant system 10, individually or collectively, can befabricated from materials such as stainless steel alloys, commerciallypure titanium, titanium alloys, Grade 5 titanium, super-elastic titaniumalloys, cobalt-chrome alloys, stainless steel alloys, superelasticmetallic alloys (e.g., Nitinol, super elasto-plastic metals, such as GUMMETAL® manufactured by Toyota Material Incorporated of Japan), ceramicsand composites thereof such as calcium phosphate (e.g., SKELITE™manufactured by Biologix Inc.), thermoplastics such aspolyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyamide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate such as hydroxyapatite (HA),corraline HA, biphasic calcium phosphate, tricalcium phosphate, orfluorapatite, tri-calcium phosphate (TCP), HA-TCP, calcium sulfate, orother resorbable polymers such as polyaetide, polyglycolide,polytyrosine carbonate, polycaroplaetohe and their combinations,biocompatible ceramics, mineralized collagen, bioactive glasses, porousmetals, bone particles, bone fibers, morselized bone chips, bonemorphogenetic proteins (BMP), such as BMP-2, BMP-4, BMP-7, rhBMP-2, orrhBMP-7, demineralized bone matrix (DBM), transforming growth factors(TGF, e.g., TGF-β), osteoblast cells, growth and differentiation factor(GDF), insulin-like growth factor 1, platelet-derived growth factor,fibroblast growth factor, or any combination thereof.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 is employed, for example, with a minimallyinvasive procedure, including percutaneous techniques, and mini-opensurgical techniques to deliver and introduce instrumentation and/or animplant, such as, for example, a bone fastener, at a surgical sitewithin a body B of a patient, which includes, for example, a spinehaving vertebrae V. Spinal implant system 10 includes an extender 12(FIG. 4) and fasteners 16, 18, 20, 22 (FIG. 6). Extender 12 isconfigured for inserting a fastener into vertebrae V. In someembodiments, a retractor (not shown) is configured to retract tissue,such as, for example, a lateral portion LP of the tissue and/or acontra-lateral portion CLP of the tissue disposed adjacent a minimallyinvasive incision I to create an access path to a surgical siteincluding vertebrae V. In some embodiments, system 10 may comprisevarious instruments, such as, for example, inserters, reducers,spreaders, distractors, blades, clamps, forceps, elevators and drills,which may be alternately sized and dimensioned, and arranged as a kit.

In some embodiments, one or more of fasteners 16, 18, 20, 22 may beengaged with tissue in various orientations, such as, for example,series, parallel, offset, staggered and/or alternate vertebral levels.In some embodiments, one or more of fasteners 16, 18, 20, 22 maycomprise multi-axial screws, sagittal angulation screws, pedicle screws,mono-axial screws, uni-planar screws, facet screws, fixed screws, tissuepenetrating screws, conventional screws, expanding screws, wedges,anchors, buttons, clips, snaps, friction fittings, compressive fittings,expanding rivets, staples, nails, adhesives, posts, fixation platesand/or posts.

Each of fasteners 16, 18, 20, 22 comprise a first portion, such as, forexample, a receiver and a second portion, such as, for example, anelongated shaft configured for penetrating tissue. The receiver includesa pair of spaced apart arms having an inner surface that defines aU-shaped passageway. One of more of the passageways are configured fordisposal of a longitudinal element, such as, for example, a spinal rod28 and/or a spinal rod 30. In some embodiments, all or only a portion ofthe passageway may have alternate cross section configurations, such as,for example, oval, oblong, triangular, square, polygonal, irregular,uniform, non-uniform, offset, staggered, and/or tapered. In someembodiments, the arms of the receiver may be disposed at alternateorientations, relative to the shaft, such as, for example, thosealternatives described herein.

In one embodiment, each of fasteners 16, 18, 20, 22 have a multi axialconfiguration such that the receiver is rotatable to a selected anglethrough and within an angular range to capture a spinal rod for fixationtherein. The inner surface of the receiver includes a thread formconfigured for engagement with a coupling member, such as, for example,a set screw. The set screw is threaded with the receiver to attach,provisionally fix and/or lock spinal rods 28, 30 with at least one offasteners 16, 18, 20, 22.

The shaft has a cylindrical cross section configuration and includes anouter surface having an external thread form. In some embodiments, theexternal thread form may include a single thread turn or a plurality ofdiscrete threads. In some embodiments, other engaging structures may belocated on the shaft, such as, for example, a nail configuration, barbs,expanding elements, raised elements and/or spikes to facilitateengagement of the shaft with tissue, such as, for example, vertebrae.

In some embodiments, all or only a portion of the shaft may havealternate cross section configurations, such as, for example, oval,oblong, triangular, square, polygonal, irregular, uniform, non-uniform,offset, staggered, undulating, arcuate, variable and/or tapered. In someembodiments, the outer surface of the shaft may include one or aplurality of openings. In some embodiments, all or only a portion of theouter surface of the shaft may have alternate surface configurations,such as, for example, smooth and/or surface configurations to enhancefixation with tissue, such as, for example, rough, arcuate, undulating,porous, semi-porous, dimpled, polished and/or textured. In someembodiments, all or only a portion of the shaft may be cannulated.

Each of spinal rods 28, 30 have a cylindrical cross sectionconfiguration. In some embodiments, system 10 may include one or aplurality of spinal rods, which may be relatively disposed in a side byside, irregular, uniform, non-uniform, offset and/or staggeredorientation or arrangement. In some embodiments, spinal rods 28, 30 canhave a uniform thickness/diameter. In some embodiments, spinal rods 28,30 may have various surface configurations, such as, for example, rough,threaded for connection with surgical instruments, arcuate, undulating,dimpled, polished and/or textured. In some embodiments, the thicknessdefined by spinal rods 28, 30 may be uniformly increasing or decreasing,or have alternate diameter dimensions along its length. In someembodiments, spinal rods 28, 30 may have various cross sectionconfigurations, such as, for example, oval, oblong, triangular,rectangular, square, polygonal, irregular, uniform, non-uniform,variable and/or tapered. In some embodiments, spinal rods 28, 30 mayhave various lengths. In some embodiments, the longitudinal element mayinclude one or a plurality of tethers.

In some embodiments, the longitudinal element may have a flexibleconfiguration and fabricated from materials, such as, for example,polyester, polyethylene, fabric, silicone, polyurethane,silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers andelastomeric composites. In one embodiment, the flexibility of thelongitudinal element includes movement in a lateral or side to sidedirection and prevents expanding and/or extension in an axial direction.In some embodiments, all or only a portion of the longitudinal elementmay have a semi-rigid, rigid or elastic configuration, and/or haveelastic properties, such as the elastic properties corresponding to thematerial examples described above. In some embodiments, the longitudinalelement may be compressible in an axial direction.

In assembly, operation and use, spinal implant system 10, similar to thesystems described herein, is employed with a surgical procedure fortreatment of a spinal disorder, such as those described herein,affecting a section of a spine of a patient. System 10 may also beemployed with other surgical procedures. To treat a section of vertebraeV, body B of a patient is disposed in a lateral orientation, as shown inFIG. 1, relative to a surgical fixed surface, such as, for example,surgical table 32 configured for supporting body B. Body B includeslateral portion LP and contra-lateral portion CLP. Portion CLP isdisposed between portion LP and surgical table 32 when body B isdisposed in the lateral orientation. In some embodiments, thecomponents, such as, implants including bone fasteners, rods, interbodydevices and plates, of spinal implant system 10 are delivered andimplanted with body B while maintaining body B in the lateralorientation, not rotating body B from the lateral orientation and/or notmoving body B into one or a plurality of alternate orientations relativeto surgical table 32. This configuration and method of use of spinalimplant system 10 reduces operating time for a surgical procedure andreduces radiation exposure due to fluoroscope or image guidance, forexample, by eliminating procedural steps and patient repositioning byimplanting system components in one body position. In one embodiment,body B is disposed in a prone orientation relative to surgical table 32.

With body B disposed in a selected orientation, a medical practitionerobtains access to a surgical site including a vertebral level V1 and avertebral level V2 of vertebrae V through a single minimally invasiveincision I in tissue, which includes soft tissue and/or muscle, of bodyB along a sagittal plane SP of body B. In one embodiment, incision I islaterally offset 1-2 mm from sagittal plane SP. In some embodiments,incision I is approximately a two inch incision over a spinous processSPP to the dorsolumbar fascia.

The tissue comprising lateral portion LP includes soft tissue comprisingmuscle, ligaments, tendons, cartilage and/or bone, which is disposedadjacent incision I. Lateral portion LP of the soft tissue ismanipulated to create an opening and access path to a surgical siteincluding vertebrae V of lateral portion LP without selectivelymanipulating contralateral portion CLP, which includes soft tissuecomprising muscle, ligaments, tendons, cartilage and/or bone of thetissue. For example, a dorsolumbar fascia of lateral portion LP isopened exposing an erector spinae aponeurosis. A dissection is madealong spinous process SPP over the lamina to elevate the multifidus toprovide a lateral window to the lamina and articular process of lateralportion LP.

A pathway is created adjacent the surgical site along a lateral side ofspinous process SPP and down the lamina to the facet of lateral portionLP. The components of spinal implant system 10 are deliveredpercutaneously through the pathway and/or a retractor (not shown) isdisposed in the pathway created in lateral portion LP, as shown in FIG.2, to create an access to vertebrae V of lateral portion LP. A force isapplied to lateral portion LP in a direction oriented away from spinousprocess SPP along a plane transverse to sagittal plane SP such that atleast a portion of a pars interarticularis of lateral portion LP isexposed. In some embodiments, spinal implant system 10 may be used withany existing surgical method or technique including open surgery,mini-open surgery, minimally invasive surgery including percutaneoussurgical implantation, whereby vertebrae V is accessed through amicro-incision, or sleeve that provides a protected passageway to thearea. Once access to the surgical site is obtained, the components ofspinal implant system 10 can be delivered or implanted.

In some embodiments, pilot holes are made in vertebral levels V1, V2 oflateral portion LP through the pars interarticularis. In someembodiments, the pilot holes are approximately 2 mm to 3 mm. In someembodiments, the pilot holes are made using a drill and the drill isre-oriented such that the drill is angled in the caudal to cephaladdirection along sagittal plane SP. In one embodiment, the drill isoriented such that drill is inclined at the same angle as the lamina. Insome embodiments, in the axial plane, the drill is moved five degreestoward spinous process SPP. In some embodiments, the drill is advancedslowly using irrigation to prevent injury to vertebrae V.

With lateral portion LP manipulated to expand the opening of incision I,fasteners 16, 18 and spinal rod 28 are delivered through incision I.Fastener 16 is delivered along a pathway, such as, for example, acortical trajectory CT disposed in alignment with vertebral level V1, asshown in FIGS. 3 and 4. In one embodiment, cortical trajectory CT isdetermined using physical landmarks and fluoroscopy simultaneously.Fastener 18 is delivered along a cortical trajectory CT, similar totrajectory CT corresponding to fastener 16, disposed in alignment withvertebral level V2. Cortical trajectories CT are offset from sagittalplane SP. Extender 12 is employed to fasten one or more of fasteners 16,18 and is disposed to resist engagement with spinous process SPP ofvertebral levels V1, V2. In some embodiments, cortical trajectories CTare disposed in planes disposed in substantially parallel alignment withsagittal plane SP. In one embodiment, cortical trajectories CT areapproximately 20 degrees medial-to-lateral and 30 degreescaudal-to-cephalad.

Fastener 16 is fastened with vertebral level V1 adjacent lateral portionLP such that fastener 16 is approximately 3 mm to 5 mm medial to thelateral edge of a pars interarticularis. Fastener 18 is similarlyfastened with vertebral level V2 adjacent lateral portion LP. Spinal rod28 is connected with fasteners 16, 18 by inserting spinal rod 28 throughthe U-shaped passageways of fasteners 16, 18 and securing spinal rod 28with set screws, as shown in FIG. 5.

The tissue includes contralateral portion CLP disposed adjacent incisionI, as shown in FIG. 6. Contralateral portion CLP is manipulated tocreate an opening and access path to a surgical site including vertebraeV of contralateral portion CLP without selectively manipulating lateralportion LP. For example, a dorsolumbar fascia of contralateral portionCLP is opened exposing an erector spinae aponeurosis. A dissection ismade along spinous process SPP over the lamina to elevate the multifidusto provide a lateral window to the lamina and articular process ofcontralateral portion CLP.

A pathway is created adjacent the surgical site along a contralateralside of spinous process SPP and down the lamina to the facet ofcontralateral portion CLP. The components of spinal implant system 10are delivered percutaneously through the pathway and/or a retractor (notshown) is disposed in the pathway created in contralateral portion CLP,as shown in FIG. 6, to create an access to vertebrae V of contralateralportion CLP. A force is applied to contralateral portion CLP in adirection oriented away from spinous process SPP along a plane of thebody transverse to the sagittal plane SP such that at least a portion ofa pars interarticularis of contralateral portion CLP is exposed. Onceaccess to the surgical site is obtained, the components of spinalimplant system 10 can be delivered or implanted.

In some embodiments, pilot holes are made in vertebral levels V1, V2 ofcontralateral portion CLP through the pars interarticularis. Withcontralateral portion CLP manipulated to expand the opening of incisionI, fasteners 20, 22 and spinal rod 30 are delivered through incision I.Fastener 20 is delivered along a cortical trajectory CT, as describedherein, disposed in alignment with vertebral level V1. Fastener 22 isdelivered along a cortical trajectory CT, as described herein, disposedin alignment with vertebral level V2. Extenders, similar to thosedescribed herein, are employed to fasten one or more of fasteners 20, 22and are disposed to resist engagement with spinous process SPP ofvertebral levels V1, V2.

Fastener 20 is fastened with vertebral level V1 adjacent contralateralportion CLP such that fastener 20 is approximately 3 mm to 5 mm medialto the lateral edge of a pars interarticularis. Fastener 22 is similarlyfastened with vertebral level V2 adjacent contralateral portion CLP.Spinal rod 30 is connected with fasteners 20, 22 by inserting spinal rod30 through the U-shaped passageways of fasteners 20, 22 and securingspinal rod 30 with set screws. Rods 28, 30 are disposed in a bilateralconfiguration with vertebral levels V1, V2, as shown in FIG. 7. In someembodiments, lateral portion LP and contralateral portion CLP aretreated without moving body B, relative to table 32, from the lateralorientation or the prone orientation.

In one embodiment, as shown in FIG. 7, while maintaining body B in aselected orientation, such as a prone or a lateral orientation, and notrotating body B from the selected orientation relative to surgical table32, an interbody implant (not shown) is delivered along a direct lateralsurgical approach or pathway DL adjacent to a surgical site andimplanted adjacent vertebral levels V1, V2. In the lateral orientation,a medical practitioner obtains access to a surgical site includingvertebral level V1 and vertebral level V2 via a lateral incision I1 withbody B through pathway DL, which includes a protected passageway,similar to those described herein. In one embodiment, the interbodyimplant is delivered along pathway DL and implanted with levels V1and/or V2 in connection with a partial or complete corpectomy, which isperformed for treating the spine disorder.

Upon completion of a procedure, described herein, the surgicalinstruments, assemblies and non-implanted components of spinal implantsystem 10 are removed and the incisions are closed. One or more of thecomponents of spinal implant system 10 can be made of radiolucentmaterials such as polymers. Radiomarkers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.In some embodiments, the use of surgical navigation, microsurgical andimage guided technologies may be employed to access, view and repairspinal deterioration or damage, with the aid of spinal implant system10. In some embodiments, spinal implant system 10 may include one or aplurality of plates, connectors and/or bone fasteners for use with asingle vertebral level or a plurality of vertebral levels.

In one embodiment, spinal implant system 10 includes an agent, which maybe disposed, packed, coated or layered within, on or about thecomponents and/or surfaces of spinal implant system 10. In someembodiments, the agent may include bone growth promoting material, suchas, for example, bone graft to enhance fixation of the components and/orsurfaces of spinal implant system 10 with vertebrae. In someembodiments, the agent may include one or a plurality of therapeuticagents and/or pharmacological agents for release, including sustainedrelease, to treat, for example, pain, inflammation and degeneration.

In one embodiment, spinal implant system 10, similar to the systemsdescribed above, includes unilateral bone fasteners, such as, forexample, facet screws (not shown) similar to the fasteners describedabove, and a bone plate (not shown), and is employed with a surgicalprocedure for treatment of a spinal disorder, similar to the methodsdescribed above. Body B (FIG. 7) is disposed in a selected orientation,as described above, relative to surgical table 32 and access to thesurgical site is obtained through a single minimally invasive incisionin tissue, described above, such that the facet screws can be deliveredor implanted with portion CLP.

A pilot hole is made in vertebral level V1 of portion CLP via theincision through articular facets of vertebral level V1 and/or adjacentvertebrae along a facet screw trajectory. The facet screw is deliveredthrough the incision to the surgical site along the facet screwtrajectory. The facet screw is fastened via an extender to immobilizethe articular facets of vertebral level V1 and/or adjacent vertebrae tosupport portion CLP of vertebrae V. A pilot hole is made in vertebrallevel V2 of portion CLP via the incision through articular facets ofvertebral level V2 and/or adjacent vertebrae along a facet screwtrajectory. The facet screw is delivered through the incision to thesurgical site along the facet screw trajectory. The facet screw isfastened via an extender to immobilize the articular facets of vertebrallevel V2 and/or adjacent vertebrae to support portion CLP of vertebraeV.

While maintaining body B in the lateral orientation and not rotatingbody B from the lateral orientation relative to surgical table 32, amedical practitioner obtains access to a surgical site includingvertebral levels V1, V2 via a lateral incision with body B thatcommunicates with a direct lateral surgical pathway. The bone plate isdelivered through the lateral incision and along the direct lateralsurgical pathway adjacent to a surgical site for implantation with ananterior portion of levels V1, V2 to support portion LP of vertebrae V.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A method for treating a spine, the methodcomprising the steps of: creating a single minimally invasive incisionin tissue of a body along a substantially sagittal plane of the body;manipulating a lateral portion of the tissue without manipulating acontralateral portion of the tissue to deliver a first fastener, asecond fastener and a first spinal rod through the incision, the firstfastener being delivered along a cortical trajectory disposed inalignment with a first vertebral level and the second fastener beingdelivered along a cortical trajectory disposed in alignment with asecond vertebral level; fastening the first fastener with the firstvertebral level adjacent the lateral portion; fastening the secondfastener with the second vertebral level adjacent the lateral portion;connecting the first spinal rod with the fasteners; manipulating thecontralateral portion without manipulating the lateral portion todeliver a third fastener, a fourth fastener and a second spinal rodthrough the incision, the third fastener being delivered along acortical trajectory disposed in alignment with the first vertebral leveland the fourth fastener being delivered along a cortical trajectorydisposed in alignment with the second vertebral level; fastening thethird fastener with the first vertebral level adjacent the contralateralportion; fastening the fourth fastener with the second vertebral leveladjacent the contralateral portion; and connecting the second spinal rodwith the third and fourth fasteners.
 2. A method as recited in claim 1,wherein the first fastener is fastened with a pars interarticularis ofthe first vertebral level.
 3. A method as recited in claim 1, whereinthe body is disposed in a lateral orientation relative to a surgicalfixed surface configured for supporting the body.
 4. A method as recitedin claim 3, further comprising the step of maintaining the body in thelateral orientation relative to the surgical fixed surface during thesteps of manipulating and fastening the fasteners.
 5. A method asrecited in claim 1, wherein the body is disposed in a prone orientationrelative to a surgical fixed surface configured for supporting the body.6. A method as recited in claim 1, wherein the cortical trajectory isoffset from the sagittal plane of the body.
 7. A method as recited inclaim 1, wherein the cortical trajectory is offset from the sagittalplane of the body and the step of fastening includes manipulating anextender to fasten one or more of the fasteners such that the extenderis disposed to resist engagement with a spinous process of the first orsecond vertebral levels.
 8. A method as recited in claim 1, wherein thefirst fastener and the second fastener are relatively disposed in asubstantially parallel orientation.
 9. A method as recited in claim 1,wherein the rods are disposed in a bilateral configuration relative tothe vertebral levels.
 10. A method as recited in claim 1, wherein thecontralateral portion is disposed between the lateral portion and asurgical fixed surface configured for supporting the body.
 11. A methodas recited in claim 1, wherein the lateral portion includes a parsinterarticularis of the first vertebral level and a parsinterarticularis of the second vertebral level.
 12. A method as recitedin claim 1, wherein the contralateral portion includes a parsinterarticularis of the first vertebral level and a parsinterarticularis of the second vertebral level.
 13. A method as recitedin claim 1, further comprising the step of delivering an interbodyimplant along a direct lateral trajectory adjacent the first vertebrallevel.
 14. A method as recited in claim 13, further comprising the stepof maintaining the body in a lateral orientation relative to a surgicalfixed surface during the step of delivering the interbody implant.
 15. Amethod as recited in claim 13, wherein the interbody implant includes anexpandable cage.
 16. A method as recited in claim 1, further comprisingthe steps of delivering a plate along a direct lateral trajectoryadjacent the first vertebral level and fastening the plate with thefirst vertebral level.
 17. A method for treating a spine, the methodcomprising the steps of: disposing a body including vertebrae in alateral orientation relative to a surgical fixed surface configured forsupporting the body; creating a single minimally invasive incision intissue of the body along a substantially sagittal plane of the body;manipulating a lateral portion of the tissue without manipulating acontralateral portion of the tissue to deliver a first fastener, asecond fastener and a first spinal rod through the incision, the firstfastener being delivered along a cortical trajectory disposed inalignment with a first vertebral level of the vertebrae and the secondfastener being delivered along a cortical trajectory disposed inalignment with a second vertebral level of the vertebrae; fastening thefirst fastener with the first vertebral level adjacent the lateralportion; fastening the second fastener with the second vertebral leveladjacent the lateral portion; connecting the first spinal rod with thefasteners; manipulating the contralateral portion without manipulatingthe lateral portion to deliver a third fastener, a fourth fastener and asecond spinal rod through the incision, the third fastener beingdelivered along a cortical trajectory disposed in alignment with thefirst vertebral level and the fourth fastener being delivered along acortical trajectory disposed in alignment with the second vertebrallevel; fastening the third fastener with the first vertebral leveladjacent the contralateral portion; fastening the fourth fastener withthe second vertebral level adjacent the contralateral portion;connecting the second spinal rod with the third and fourth fasteners;and maintaining the body in the lateral orientation relative to thesurgical fixed surface during the steps of manipulating and fasteningthe fasteners.
 18. A method as recited in claim 17, further comprisingthe step of delivering an interbody implant along a direct lateraltrajectory adjacent the first vertebral level.
 19. A method as recitedin claim 17, further comprising the steps of delivering a plate along adirect lateral trajectory adjacent the first vertebral level andfastening the plate with the first vertebral level.
 20. A method fortreating a spine, the method comprising the steps of: disposing a bodyincluding vertebrae in a lateral orientation relative to a surgicalfixed surface configured for supporting the body; creating a singleminimally invasive incision in tissue of the body along a substantiallysagittal plane of the body; manipulating a lateral portion of the tissuewithout manipulating a contralateral portion of the tissue to deliver afirst fastener, a second fastener and a first spinal rod through theincision, the first fastener being delivered along a cortical trajectorydisposed in alignment with a first vertebral level of the vertebrae andthe second fastener being delivered along a cortical trajectory disposedin alignment with a second vertebral level of the vertebrae; fasteningthe first fastener with the first vertebral level adjacent the lateralportion; fastening the second fastener with the second vertebral leveladjacent the lateral portion; connecting the first spinal rod with thefasteners; manipulating the contralateral portion without manipulatingthe lateral portion to deliver a third fastener, a fourth fastener and asecond spinal rod through the incision, the third fastener beingdelivered along a cortical trajectory disposed in alignment with thefirst vertebral level and the fourth fastener being delivered along acortical trajectory disposed in alignment with the second vertebrallevel; fastening the third fastener with the first vertebral leveladjacent the contralateral portion; fastening the fourth fastener withthe second vertebral level adjacent the contralateral portion;connecting the second spinal rod with the third and fourth fasteners;maintaining the body in the lateral orientation relative to the surgicalfixed surface during the steps of manipulating and fastening thefasteners; and delivering an interbody implant along a direct lateraltrajectory adjacent the first vertebral level without moving the bodyfrom the lateral orientation.